← Back to Search

Protein Kinase Inhibitor

Silmitasertib + Chemotherapy for Recurrent Solid Tumors

Phase 1 & 2
Recruiting
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Age: Less than 30 years old at initial diagnosis
2. Pathology All subjects must have a confirmed diagnosis of tumor type. Phase I: Relapsed/refractory solid tumors: Neuroblastoma, Ewing Sarcoma, Osteosarcoma, Rhabdomyosarcoma, Liposarcoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study a new drug called silmitasertib, taken as a pill, along with approved drugs for solid tumors. The goals include finding the right dose of silmitasert

Who is the study for?
This trial is for young patients under 30 years old initially diagnosed with specific solid tumors like Neuroblastoma, Ewing Sarcoma, Osteosarcoma, Rhabdomyosarcoma, or Liposarcoma that have not responded to treatment or have come back after treatment. Patients must have a confirmed diagnosis and meet certain criteria based on their type of cancer.
What is being tested?
The study tests Silmitasertib (a pill) combined with chemotherapy drugs Irinotecan, Temozolomide, and Vincristine in patients with relapsed or refractory solid tumors. It aims to find the right dose of Silmitasertib when used with these chemotherapies and assess its safety and effectiveness against the cancers.
What are the potential side effects?
Potential side effects may include typical chemotherapy-related issues such as nausea, vomiting, hair loss, fatigue; plus any unknown risks from Silmitasertib since it's an investigational drug not yet approved by regulatory authorities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed before turning 30.
Select...
My cancer is one of the specified types and has come back or didn’t respond to treatment.
Select...
My neuroblastoma has come back or didn't respond to treatment.
Select...
My neuroblastoma is classified as L2, MS, or M with MYCN amplification.
Select...
I am at least 547 days old and my cancer is at an advanced stage.
Select...
My Ewing sarcoma has come back or didn't respond to treatment.
Select...
My neuroblastoma has returned after completing standard treatment.
Select...
My high-risk neuroblastoma hasn't responded to at least 4 treatment cycles or has worsened.
Select...
I was diagnosed at any age with a specific stage of neuroblastoma that worsened without chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase I- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Phase I- Number of Participants with Dose Limiting Toxicities to determine RP2D
Phase II- Determine the Overall Response Rate (ORR) of Participants using INSS Response
Secondary study objectives
Number of participants with progression free survival (PFS) during study
Phase I- Determine the Overall Response Rate (ORR) of Participants using INSS Response
Phase II- Length of time that participants experience Overall Survival (OS)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase II- Relapsed/refractory NeuroblastomaExperimental Treatment3 Interventions
Silmitasertib RP2D twice a day plus Irinotecan and Temozolomide
Group II: Phase II- Relapsed/refractory Ewing sarcomaExperimental Treatment4 Interventions
Silmitasertib RP2D twice a day plus Vincristine, irinotecan and temozolomide
Group III: Phase I- Dose level 2Experimental Treatment4 Interventions
Silmitasertib 800 mg/m2 twice a day plus Neuroblastoma: Regimen A: Irinotecan and Temozolomide Sarcoma: Regimen B: Vincristine, Irinotecan and Temozolomide
Group IV: Phase I- Dose level 1Experimental Treatment4 Interventions
Silmitasertib 600 mg/m2 twice a day plus Neuroblastoma: Regimen A: Irinotecan and Temozolomide Sarcoma: Regimen B: Vincristine, Irinotecan and Temozolomide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Silmitasertib
2020
Completed Phase 2
~20
Irinotecan
2017
Completed Phase 3
~2590
Temozolomide
2010
Completed Phase 3
~1880
Vincristine
2003
Completed Phase 4
~2970

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
508 Previous Clinical Trials
2,796,230 Total Patients Enrolled
1 Trials studying Osteosarcoma
253 Patients Enrolled for Osteosarcoma
Chandrika Behura, MDStudy ChairPenn State Health Children's Hospital
~76 spots leftby Nov 2030
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top